Form Approved Through 6/30/2012 Department of Health and Human Services Council; 05/2011 r>..i~<:. '-(gaith Services PI: ANASTOS, KATHRYN M 1 2 1 6 1 5 3 7 application 1 U01 AI096299-01 AIDS/EXPED r length restrictions indicated. Dual:CA,HD Received: 11/12/2010 IRG: ZAI1 SRC(99) 1. TITLE OF PROJECT (Do not exceed 81 characters, including spaces a< Central Africa leDEA 2. RESPONSE TO SPECIFIC REQUEST FOR APPLICATIONS OR PROGRAM ANNOUNCEMENT OR SOLICITATION Q NO i ^ YES (If Yes, state number and title) Number: RFA-AI-10-030 Title: International Epidemiologic Databases to Evaluate AIDS (leDEA) 3. PROGRAM DIRECTOR/PRINCIPAL INVESTIGATOR 3a. NAME (Last, first, middle) 3b. DEGREE(S) 3h. eRA Commons User Name Anastos, Kathryn Mary MD kanastos 3c. POSITION TITLE 3d. MAILING ADDRESS fS^reef, city, state, zip code) Professor of Medicine, Epidemiology and Population Health 3311 Bainbridge Avenue 3e. DEPARTMENT, SERVICE, LABORATORY, OR EQUIVALENT Bronx, NewYork 10467 Department of Medicine 3f. MAJOR SUBDIVISION Dept. of Epidemiology and Population Health 3g. TELEPHONE AND FAX (Area code, number and extension) E-MAIL ADDRESS: TEL: 718-515-2593 FAX: kathryn.anastos@einstein.yu.edu HUMAN SUBJECTS RESEARCH 4a. Research Exempt If Yes, Exemption No. S No n Yes 13 No n Yes 4b. Federal-Wide /^surance No. 4c. Clinical Trial 4d. NIH-defined Phase III Clinical Trial ISI No D Yes Kl No n Yes 5. VERTEBRATE ANIMALS S No D Yes 5a. Animal Welfare Assurance No. DATES OF PROPOSED PERIOD OF COSTS REQUESTED FOR INITIAL 8. COSTS REQUESTED FOR PROPOSED SUPPORT (month, day. vear?MM/DD/yY) BUDGET PERIOD PERIOD OF SUPPORT From Through 7a. Direct Costs ($) 7b. Total Costs ($) 8a. Direct Costs ($) 8b. Total Costs ($) 07/01/11 06/30/16 $1,570,965 $1,999,581 $8,017,667 9997639 9. APPLICANT ORGANIZATION 10. TYPE OF ORGANIZATION Name Albert Einstein College of Medicine Public: -^ Federal Q State Local Address ^ 300 Morris Park Avenue Private: -> ^ Private Nonprofit Bronx, NewYork 10461 For-profit: -> CH General CH Small Business I I Woman-owned CH Socially and Economically Disadvantaged 11. ENTITY IDENTIFICATION NUMBER 113-1624225A2 DUNS NO. 110521739 Icong. District NY-007 12. ADMINISTRATIVE OFFICIAL TO BE NOTIFIED IF AWARD IS MADE 13. OFFICIAL SIGNING FOR APPLICANT ORGANIZATION Name Mr. Robert Ness Name Allen M. Spiegel, MD Title Associate Director for Grant Accounting Title Dean Address 1300 Morris Park Avenue Address ^gQQ Morris Park Avenue, Bronx, NY 10461 Bronx, New York 10461-1602 Tel: 718 320 3712 FAX: 718 430 8675 E-Mail: aorrn(gaecom.yu.edu 14. APPLICANT ORGANIZATION CERTIFICATION AND ACCEPTANCE: I certify that the statements herein are true, complete and accurate to the best of my knowledge, and accept the obligation to comply with Public Health Services terms and conditions if a grant is awarded as a result of this application. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. PHS 398 (Rev. 6/09) Face Page Tel: 718 430 2801 FAX: 718 430 8122 E-Mail: business@einstein.yu.edu SIGNATURE OF OFFICIAL NAMED IN 13 DATE (Inink. Persignaturendtaccpdtable.) Form Page 1 Use only if preparing an application with Multiple PDs/Pls. See http://qrants.nih.qov/qrants/multi pi/index.htm for details. Contact Program Director/Principal Investigator (Last, First, Middle): A n a S t O S , K a t h r y n M a r y 3. PROGRAM DIRECTOR / PRINCIPAL INVESTIGATOR 3a. NAME (Last, first, middle) Hoover, Donald R. 3c. POSITION TITLE Professor Se. DEPARTMENT, SERVICE, LABORATORY, OR EQUIVALENT Statistics and Biostatistics 3f. MAJOR SUBDIVISION Institute for Health, Health Care Policy and Aging 3g. TELEPHONE AND FAX (Area code, number and extension) TEL: 732-445-2690 FAX: 732-445-3428 3. PROGRAM DIRECTOR / PRINCIPAL INVESTIGATOR 3a. NAME (Last, first, middle) 3c. POSITION TITLE 3e. DEPARTMENT, SERVICE, LABORATORY, OR EQUIVALENT 3f. MAJOR SUBDIVISION 3g. TELEPHONE AND FAX (Area code, number and extension) TEL: FAX: 3. PROGRAM DIRECTOR / PRINCIPAL INVESTIGATOR 3a. NAME (Last, first, middle) 3c. POSITION TITLE 3e. DEPARTMENT, SERVICE, LABORATORY, OR EQUIVALENT 3f. MAJOR SUBDIVISION 3g. TELEPHONE AND FAX (Area code, number and extension) TEL: FAX: 3. PROGRAM DIRECTOR / PRINCIPAL INVESTIGATOR 3a. NAME (Last, first, middle) 3c. POSITION TITLE 3e. DEPARTMENT, SERVICE, LABORATORY, OR EQUIVALENT 3f. MAJOR SUBDIVISION 3g. TELEPHONE AND FAX (Area code, number and extension) TEL: FAX: PHS 398 (Rev. 6/09) Face 3b. DEGREE(S) 3h. NIH Commons User Name PhD MPH drhoover 3d. MAILING ADDRESS (^Sfreef, city, state, zip code) 110 Frelinghuysen Road, Room 1107 New Brunswick, New Jersey E-MAIL ADDRESS: donhoover@aol.com 3b. DEGREE(S) 3d. MAILING ADDRESS E-MAIL ADDRESS: 3b. DEGREE(S) 3d. MAILING ADDRESS E-MAIL ADDRESS: 3b. DEGREE(S) 3d. MAILING ADDRESS E-MAIL ADDRESS: Page-continued 3h. NIH Commons User Name (Street, city, state, zip code) 3h. NIH Commons User Name (Street, city, state, zip code) - 3h. NIH Commons User Name (^Sfreef, city, state, zip code) Form Page 1-continued Program Director/Principal Investigator (Last, First, Middle): A n a S t O S , K a t h r y n M a r y PROJECT SUMMARY (See instnjctions): The promise of antiretroviral therapy (ART) to provide renewed health is now being realized for millions of Africans. As HIV care and treatment programs are implemented throughout Africa, careful monitoring of their effectiveness is of crucial importance, so that care and treatment resources can be deployed to optimal benefit. Immunologic and clinical responses to ART, retention in care, and behavioral components (e.g. treatment adherence) need to be elucidated and predictors of survival defined. The impact of HIV and ART on cancers in Africa is essentially undescribed, and interactions with major ambient comorbidities such as malaria are pooriy understood. We propose a new Central Africa leDEA (CA-leDEA), designed to optimize and augment scientific productivity and rapid, high-impact publications; we will 1.) Compile and manage secondary source patient-level data on a large volume of patients through a.) extraction from existing electronic data, or b.) new on-the-ground systems for efficient capture of clinical data in low-resource clinical settings; 2.) Develop a creative and flexible scientific process that fosters high throughput of many analyses of data to answer epidemiologic, operational and other HIV-related research questions, culminating in high- impact publications; and 3.) Develop capacity for independent research, data management, analysis and publication in each of the Central African countries over five to ten years, ensuring the sustainability of CA- leDEA. Our team brings a long history in the region of research productivity and operational success, as well as innovative IT development to support research, with complementary skills and experience to optimize the activities of CA-leDEA. Four of our partners are the implementers of HIV care services (i.e. the governments) and the fifth partner, WE-ACTx Rwanda, brings patient volume, research experience and special resources to investigate AIDS malignancies. We will develop an administrative and data management infrastructure that supports the implementation of epidemiologic and implementation science to answer key questions in HIV care and treatment in lower-resource settings, with integrated research teams in the US, Cameroon and Rwanda. RELEVANCE (See instructions): Sub-Saharan AFrica bears the greatest burden of HIV disease globally. Research to define clinical and epidemiologic predictors of treatment success is needed to guide clinicians caring for persons with HIV. In addition, implementation science can guide policy makers and program implementers on service delivery mechanisms to provide most efficient use of treatment resoures and the optimal gain to the public's health.